Accutane (isotretinoin) was developed by Hoffman-La Roche to treat severe acne symptoms. After receiving FDA approval in 1982, Accutane was hailed as a miracle drug for its ability to cure acne symptoms that had previously resisted treatment.
Accutane was so successful at treating severe acne symptoms that many doctors began prescribing it to treat much milder cases.
Accutane birth defects
As more patients took Accutane, its side effects and dangers became known. Roche had developed Accutane more than a decade before releasing it, but the company had decided against marketing the drug because of the severe risk of birth defects.
As sales of Accutane climbed in the 1980s, however, thousands of women—unaware of the side effects and dangers it posed—used the drug during pregnancy. A 1990 FDA memo said that 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects had occurred. [Timeline of events]
One official at the Centers for Disease Control compared Accutane with the notorious drug Thalidomide, which was known to cause birth defects in the late 1950s and early 1960s. FDA officials estimate that Accutane causes birth defects in about 30% of women who become pregnant while taking it.
The iPLEDGE program
In response to the alarming number of abortions and birth defects among Accutane patients, Roche was forced to institute a patient-awareness program called iPLEDGE. The program requires women to get regular pregnancy tests and to use two forms of birth control.
Despite Roche’s iPLEDGE program, the FDA was extremely critical of its response to the Accutane side effects and birth defects. As far back as 1990, the agency had called for Accutane to be taken off the market due to the extreme risks it posed to public health as a cause of birth defects.
A 1998 FDA memo accused Roche of trying to suppress information about the pregnancy dangers posed by Accutane, saying that the company “had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure.” The memo again called for Accutane to be taken off the market.
In November 2004, Dr. David Graham of the FDA’s Center for Drug Evaluation and Research put Accutane on his list of the five most dangerous drugs on the market. [More expert testimony on Accutane]
If you or a loved one has used Accutane and experienced side effects, call the law office of Hissey Kientz, toll-free at (866) 275-4454 or fill out a free online case evaluation form to the top right of this page.